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FDA 510(k)

BRAINTRACE

K-Number: K940811 · 1995-05-02

ApplicantBrainstorms Monitoring Corp.
Decision Date1995-05-02
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRAINTRACE is the device name listed in this FDA 510(k) record. The listed applicant is Brainstorms Monitoring Corp.. It received FDA 510(k) clearance on 1995-05-02 under 510(k) number K940811. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAINTRACE?

BRAINTRACE is a medical device that received FDA 510(k) clearance on 1995-05-02. The listed applicant is Brainstorms Monitoring Corp.. The 510(k) number is K940811.

When did BRAINTRACE receive FDA 510(k) clearance?

BRAINTRACE received FDA 510(k) clearance on 1995-05-02, under 510(k) number K940811.

Who is the listed applicant for BRAINTRACE?

The FDA 510(k) record lists Brainstorms Monitoring Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRAINTRACE?

The FDA product code for BRAINTRACE is OLT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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